Mesitylene

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Remarks:

Read-across to the test material (Shellsol A) is justified by the description of its composition – it is described as being composed of predominantly trimethylbenzenes, of which mesitylene is one.

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP, near-guideline study, available as unpublished report, restrictions in design and/or reporting but otherwise adequate for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

64742-95-6

Cas Number:

64742-95-6

IUPAC Name:

64742-95-6

Constituent 2

Reference substance name:

Shellsol A

IUPAC Name:

Shellsol A

Details on test material:

- Name of test material (as cited in study report): Shellsol A
- Substance type: hydrocarbon solvent (essentially C9 isomers, particularly trimethylbenzenes)
- Physical state: liquid
- Source: Shell Nederland Raffinarderij B.V. refinery, Pernis, Rotterdam, The Netherlands

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

- Source: Ranch Rabbits, Crawley, Sussex, UK
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES: no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.2 mL undiluted Shellsol A

Duration of treatment / exposure:

single instillation

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

2 male and 2 female

Details on study design:

Shellsol A instilled into conjunctival sac of right eye, untreated left eye served as a control. Eye irritation assessed 1,2,3 and 7 days after instillation according to numerical scheme cited in Federal Register (28 (110), 6.6.1963. para 191.12. Test for eye irritation)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

>= 0 - <= 1

Max. score:

2

Reversibility:

fully reversible within: 1 day

Remarks:

after 30 min. highest schore of 2 for two animals

Remarks on result:

probability of weak irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

>= 0 - <= 1

Max. score:

2

Reversibility:

fully reversible within: 1 day

Remarks:

after 30 min.: score of 2 for one animal and score of 1 for 3 animals

Irritant / corrosive response data:

Thirty minutes after instillation, slight to moderate conjunctival redness was present in all 4 rabbits and slight to moderate chemosis was present in 3 rabbits. Conjunctival discharge was present in one rabbit at the 30 minute and day 1 reading but did not persist. These conjunctival effects did not persist, no chemosis was seen after 1 day, very slight redness was seen in 2 rabbits at 1 day but all redness had cleared by day 2. There were no corneal or iridial effects.

Other effects:

There was an immediate pain reaction following instillation into the eye.

Any other information on results incl. tables

Eye irritation scores of Shellsol A

Time		Cornea				Iris				Conjunctiva
										Redness				Chemosis
	Animal number	9	10	56	57	9	10	56	57	9	10	56	57	9	10	56	57
after 30 mins		0	0	0	0	0	0	0	0	2	1-2	1	1	2	1	0-1	0
after 1 day		0	0	0	0	0	0	0	0	0-1	0	0-1	0	0	0	0	0
after 2 days		0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
after 3 days		0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
after 7 days		0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

other: EU GHS: not irritating

Conclusions:

Shellsol A was practically non-irritating to the rabbit eye.

Executive summary:

One drop (0.2 mL) of Shellsol A instilled into the rabbit eye caused an immediate pain reaction but thereafter was practically non-irritating.